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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized as a focus on the practical aspects of study design which include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for pragmatic trials to be reliable and lessen the chance of bias is also essential. However, too much heterogeneity can result in problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to inform their decision making. They also provide a useful method to determine the causal relationship between an intervention and its outcomes. However, they shouldn't be used as a substitute for explanatory studies.
The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study which includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.